Prevalence and profile of nocturnal disturbances in Chinese patients with advanced-stage Parkinson's disease: a cross-sectional epidemiology study.

BACKGROUND: The impact of nocturnal disturbance (ND) in Parkinson's disease on quality of life of patients in Western Countries is increasingly understood. Our study aimed to investigate ND prevalence and its quality of life impact in patients with advanced Parkinson's disease in China. METHODS: In a multicenter, tertiary-care hospital, outpatient-based, cross-sectional study, patients with advanced Parkinson's disease (Modified Hoehn & Yahr [H&Y] Stage II-IV with ≥3 h awake "off" time/day) from 10 tertiary hospitals throughout China completed the Parkinson's Disease Sleep Scale-2 (PDSS-2) and Parkinson's Disease Questionnaire-39 (PDQ-39). The primary endpoint was the percentage of patients with significant ND (PDSS-2 total score ≥ 15). Additional endpoints were demographic and clinical characteristics, PDSS-2 and PDQ-39 total and subscale scores, correlation between PDSS-2 and PDQ-39, and risk factors for ND and higher PDSS-2 or PDQ-39 scores. RESULTS: Of 448 patients analyzed (mean age 63.5 years, 47.3% female), 70.92% (95% confidence interval: 66.71, 75.13) had significant ND. Presence of ND and higher PDSS-2 scores were associated with longer disease duration and higher H&Y stage. Presence of ND was also associated with more awake "off" time/day and female sex. PDQ-39 scores were significantly worse for patients with ND versus those without ND; worse scores were associated with more awake "off" time/day, female sex, and higher H&Y stage. PDSS-2 and PDQ-39 total scores were associated: Pearson correlation coefficient 0.62 (p < 0.001). CONCLUSIONS: In China, ND was highly prevalent in patients with advanced Parkinson's disease and adversely impacted quality of life. This study highlights the importance of early diagnosis and optimized management of ND in patients with Parkinson's disease in China.

Safety of retigabine in adults with partial-onset seizures after long-term exposure: focus on unexpected ophthalmological and dermatological events.

BACKGROUND: Retigabine is an antiepileptic drug developed for the adjunctive treatment of adults with epilepsy and partial-onset seizures (POS). Following its approval in 2011, reports of ophthalmological/dermatological pigmentation/discoloration led to a restriction of the indication in 2013, and in 2017, retigabine was voluntarily withdrawn from the market because of its limited usage. Here, data are reported from four open-label extension studies focusing on long-term safety with particular emphasis on ophthalmological and dermatological events. METHODS: Studies 113413 (NCT01336621), 114873 (NCT01777139), 115097 (NCT00310388), and 115098 (NCT00310375) were multicenter, open-label extension studies of retigabine (300-1200 mg/day) for the adjunctive treatment of adults with POS. Safety assessments included monitoring treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). When new safety issues were identified, protocols were amended to include additional on-treatment safety evaluations, including ophthalmological and dermatological examinations. Patients who had abnormal retinal pigmentation, unexplained vision change, pigmentation of nonretinal ocular tissue, or abnormal discoloration of skin, lips, nails, and/or mucosa at the end of the treatment phase were asked to enter a safety follow-up continuation phase comprising 6-monthly ophthalmological/dermatological assessments. RESULTS: The safety population (patients receiving ≥1 dose of retigabine in the open-label phase) comprised 98, 30, 376, and 181 patients for studies 113413, 114873, 115097, and 115098, respectively. Mean (standard deviation) treatment exposure ranged from 529 (424) to 1129 (999) days. In total, 68%-96% and 4%-27% of patients across the studies experienced TEAEs and TE SAEs, respectively. There were seven on-treatment deaths and two after discontinuation. Overall, 14%-73% of patients had an on-treatment eye examination, of whom 8/53, 4/22, 17/54, and 14/36 had abnormal retinal pigmentation and 15/53, 7/22, 15/54, and 11/36 had nonretinal ocular pigmentation in studies 113413, 114873, 115097, and 115098, respectively. Four patients had confirmed acquired vitelliform maculopathy. In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, retinal pigmentation resolved completely in 1/3, 0/3, 0/10, and 1/7 patients and nonretinal ocular pigmentation in 1/4, 0/3, 8/10, and 4/6 patients, respectively. Overall, 12%-83% of patients had an on-treatment dermatological examination, of whom 11/58, 0/25, 23/46, and 23/37 had any-tissue discoloration, respectively. In patients with unresolved events at discontinuation and ≥1 posttreatment follow-up, discoloration of skin, lips, nails, and/or mucosa resolved completely in 2/3, 0/0, 7/13, and 1/11 patients, respectively. CONCLUSIONS: The safety profile of retigabine in adults with POS across four open-label studies was generally consistent with data from previous placebo-controlled studies. Discoloration of various tissues occurred in a proportion of patients treated with retigabine and resolved completely in a small number of these patients following treatment discontinuation. In addition, comprehensive eye examination identified a new adverse reaction of acquired vitelliform maculopathy in a limited number of patients.

Epidemiology of diabetes mellitus in young population in rural districts of northern Bihar.

Diabetes mellitus is a major public health problem worldwide, and it is a known risk factor for coronary artery disease. Younger population, a group which lacks epidemiological data on diabetes mellitus, the prevalence of diabetes in them was investigated in the rural districts of north Bihar (India). Furthermore, the risk factors associated with diabetes mellitus in this younger population were also assessed. A total of 3957 subjects in the age group of 12-30 years from northern Bihar participated in the study. Data were obtained from history, random capillary blood glucose levels detected by glucometer and body mass index. Of the available 3955 results, glucometer identified 103 subjects (2.6%) as positives with the cut-off value of 150 mg/dl. Out of these, 12 (0.3%) were diabetic while 35 (0.88%) had impaired glycaemic control by intravenous blood sugar method. The random blood glucose levels varied from 53-391 mg/dl (mean and SD: 105.3 and 21.2). Amongst these subjects; only 103 (2.6%) were declared to be diabetic. The fasting and postprandial blood glucose levels for diabetic subjectes were 148.5 and 227.1 mg/dl respectively. The logistic regression evidenced that positive glucometer results was associated with age (> 25 years), sex (male), high BMI (> 18.5), high BP (> 120/80) and occupation. The increasing prevalence of diabetes in young may have adverse effects on nation's health and economy. Data from this study highlights the importance of early screening, diagnosis and management of diabetes mellitus.

Anti-inflammatory effect of the serratiopeptidase--rationale or fashionable: a study in rat paw oedema model induced by the carrageenan.

INTRODUCTION: Many drugs, including serratiopeptidases, are marketed without proven efficacy in clinical trials. It is protein in nature and claimed to be effective orally. METHODS: 24 albino wistar rats, 6 each in following groups were assigned--(1) Control group (distilled water, orally) (2) Diclofenac (6.75 mg/kg, IP) (3) serratiopeptidase (5.4 mg/kg, orally) (4) Combination of serratiopeptidase (5.4 mg/kg, orally) and diclofenac (2.25 mg/kg, IP). Inflammatory agent, carrageenan (0.1 ml of 1% w/v) was injected subcutaneously in the ether anesthetized rat hind paw, half an hour after the administration of drug. Rat paw volume up to lateral malleolar process was recorded with plethysmometer at various time periods. RESULTS: Percentage formation and inhibition of oedema in serratiopeptidase or combination groups were not significantly different than control group. Both were significantly less for diclofenac group. CONCLUSION: Serratiopeptidase was not effective in this animal model of oedema/inflammation.